BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2880098 · Received December 19, 2012

    Report

    Report Number
    1644487-2012-03400
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM- CORRECT DATA: INFORMATION REGARDING THE DISABLEMENT AND REFERRAL FOR REVISION WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT IS HAVING AN INCREASE IN SEIZURES AND THAT SHE FELT THAT THE VNS WAS MISFIRING AT DIFFERENT STRENGTHS. THE MOTHER INDICATED THAT PATIENT DOES NOT HAVE GRAND MAL SEIZURES, BUT IS PASSING OUT WHICH SHE FEELS COULD BE DUE TO SUPRAVENTRICULAR TACHYCARDIA (SVT). THE MOTHER ALSO INDICATED THAT THE PATIENT HAS EXPERIENCED SUPRAVENTRICULAR TACHYCARDIA PREVIOUSLY WHEN THE DEVICE SETTINGS WERE TOO HIGH. THIS WILL BE REPORTED UNDER MANUFACTURER'S REPORT # 1644487-2012-03398. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT'S DEVICE WAS DISABLED AND THE PATIENT WAS REFERRED FOR A BATTERY REPLACEMENT AS IT WAS INDICATED THAT THE BATTERY MAY BE REACHING END OF SERVICE. REVISION IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A GENERATOR REPLACEMENT PROCEDURE ON (B)(6) 2012. AT THE TIME, IT WAS INDICATED THAT THE LEAD IMPEDANCE WAS OK. THE GENERATOR HAS BEEN RETURNED FOR ANALYSIS; HOWEVER PRODUCT ANALYSIS IS NOT YET COMPLETE.ATTEMPTS FOR ADDITIONAL INFORMATION HAVE REMAINED UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENT. THE PHYSICIAN RESPONDED TO OUR REQUEST FOR ADDITIONAL INFORMATION BUT WAS NOT ABLE TO ADDRESS THE QUESTIONS AS HE HAD A DIFFERENT UNDERSTANDING OF THE SEQUENCE OF EVENTS TO THE INITIAL REPORT. DURING (B)(6) 2012 APPOINTMENT THERE WERE NO SEIZURES REPORTED AND THE PATIENT DENIED ANY ADVERSE EVENTS OR EVENTS RELATED TO VNS. THE PHYSICIAN DECIDED NOT TO RUN DIAGNOSTICS AT THIS APPOINTMENT AS THE PATIENT WAS AT LOW SETTINGS AND HE FELT THAT DIAGNOSTICS WHICH RUN AT 1 MA MAY CAUSE ADVERSE EVENTS. WITH REVIEW OF THE PATIENT'S PROGRAMMING HISTORY HE FELT THAT GENERATOR MAY LAST SEVERAL MORE YEARS. HE DID NOT REFER THE PATIENT FOR A GENERATOR REPLACEMENT, HOWEVER HE DID RECOMMEND THAT THE PATIENT FOLLOW-UP WITH A CARDIAC ELECTROPHYSIOLOGY SUB-SPECIALIST BEFORE UNDERGOING ANY SUCH PROCEDURE. SINCE HE WAS UNAWARE OF THE INCREASE IN SEIZURES, ERRATIC STIMULATION AND ARRHYTHMIA FROM THE ERRATIC STIMULATION HE IS UNABLE TO PROVIDE ANY INFORMATION ABOUT THE EVENTS. FOLLOW-UP WITH THE CARDIOLOGIST INDICATED THEY HAD NOT SEEN THE PATIENT SINCE 2009 SO THEY WERE UNABLE TO PROVIDE ANY INFORMATION ABOUT THE CURRENT EVENTS. PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016030

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other| R